The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Standardized Uptake Value
研究概览
简要总结
This pilot trial studies how well fluorine F 18 clofarabine positron emission tomography (PET)/computed tomography (CT) works in imaging patients with autoimmune or inflammatory diseases. Fluorine F 18 clofarabine is an imaging agent or tracer which may be taken up by inflammatory tissue in the body. Diagnostic imaging, such as PET/CT scans, can be used to measure the amount of injected tracer that is taken up by inflammatory tissue. PET/CT scan may help to determine how fluorine F 18 clofarabine is distributed throughout the body.
详细描述
PRIMARY OBJECTIVES:
I. Determine how fluorine F 18 clofarabine (18F-clofarabine) is distributed in the body, in patients with autoimmune and inflammatory diseases.
II. Determine whether 18F-clofarabine can be used to image patients with autoimmune and inflammatory diseases.
OUTLINE:
Patients receive fluorine F 18 clofarabine intravenously (IV) and undergo a single PET/CT scan for up to 120 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 years or older.
- •Diagnosed with an autoimmune and inflammatory disorder.
- •Exclusion Criteria
- •Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge.
- •Patients unable to undergo or comply with PET/CT scanning due to pre-existing medical conditions including claustrophobia.
排除标准
- 未提供
结局指标
主要结局
Standardized Uptake Value
时间窗: Baseline up to 240 minutes after injection
Standardized Uptake Value (SUV) will be the primary unit for assessment. Using standard PET/CT viewing software, the SUV will be measured for different organs and lesions of suspected disease and compared to reference/background tissues.
次要结局
未报告次要终点